Intelligent Surgery Knee

JSON twin: https://www.healthaidb.com/software/intelligent-surgery-knee.json

Company Name

Enhatch

Product URL

https://www.enhatch.com/intelligent-surgery-knee

Company URL

https://www.enhatch.com

Categories

• clinical Care
• diagnostic Support
• surgical Planning
• imaging Software
• Clinical
• Diagnostic
• Medical Imaging
• Orthopedics

Summary

Enhatch's Intelligent Surgery Knee is an AI-driven system that converts patient X-rays or CT images into detailed 3D models for personalized total knee arthroplasty planning, enhancing surgical precision and efficiency.

Description

Enhatch's Intelligent Surgery Knee utilizes advanced AI algorithms to transform patient X-rays or CT scans into detailed 3D anatomical models, facilitating personalized surgical planning for total knee arthroplasty. The system includes the FitCode™ Implant Recognition Engine, optimizing implant selection and positioning for the U2 Total Knee System by United Orthopedic. It operates on a cloud-integrated platform, streamlining data management and collaboration among surgical teams. The system has received FDA 510(k) clearance, ensuring compliance with medical device standards. By reducing reliance on traditional CT scans, it offers a safer and more cost-effective approach to preoperative planning, aiming to improve patient outcomes and surgical efficiency.

Api Available

unknown

Certifications

• FDA 510(k) Clearance
• SOC 2 Type II
• HIPAA
• HITECH

Company Founding

2019

Company Offices

• United States

Compliance

• HIPAA
• HITECH
• SOC 2 Type II
• FDA 510(k) Clearance

Customers

• United Orthopedic Group

Data Residency

US-only

Data Standards

• DICOM
• HL7
• FHIR

Deployment Model

• SaaS

Features

• Advanced AI Algorithms for X-ray or CT segmentation
• 3D Anatomical Modeling for personalized surgical planning
• FitCode™ Implant Recognition Engine for implant selection and positioning
• Cloud-Integrated Platform for efficient data management
• 510(k) Cleared for patient-specific instrument design
• Precision and Customization of surgical guides and plans

Id

SW0275

Integration Partners

• 3D Systems
• United Orthopedic Group

Integrations

• United Orthopedic’s U2 Knee System
• 3D Systems Healthcare

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Virtual Surgical Planning
• Personalized Solutions
• 3D Printing by 3D Systems
• Medical Device Surgical Case Plan

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

enterprise_quote

Privacy Features

• BAA available
• Consent Management
• Anonymization
• Data Minimization

Product Code

SW0275

Product Name

Intelligent Surgery Knee

Ratings

• FDA 510(k) Cleared for Patient-Specific Instrumentation
• AI-Powered Surgical Planning Solution
• Advanced Imaging and 3D Modeling Capabilities
• FitCode™ Implant Recognition Engine
• Cloud-Based Data Management Platform

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

2024

Security Features

• Encryption
• RBAC
• Audit Logs
• 2FA

Specialties

• Orthopedics
• Knee Surgery
• Sports Medicine
• Rehabilitation

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

Target Users

• orthopedic surgeons
• surgical planners
• medical device manufacturers
• healthcare providers

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• The AI-driven approach has significantly improved our surgical planning efficiency.
• Integrating the Intelligent Surgery Knee system streamlined our preoperative processes.
• The 3D anatomical modeling feature provides precise visualization for better surgical outcomes.
• FitCode™ has optimized our implant selection, reducing time spent on planning.
• The cloud-integrated platform allows seamless collaboration among surgical teams.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "Intelligent Surgery Knee",
  "company_name": "Enhatch",
  "product_url": "https://www.enhatch.com/intelligent-surgery-knee",
  "company_url": "https://www.enhatch.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0275",
  "summary": "Enhatch's Intelligent Surgery Knee is an AI-driven system that converts patient X-rays or CT images into detailed 3D models for personalized total knee arthroplasty planning, enhancing surgical precision and efficiency.",
  "description": "Enhatch's Intelligent Surgery Knee utilizes advanced AI algorithms to transform patient X-rays or CT scans into detailed 3D anatomical models, facilitating personalized surgical planning for total knee arthroplasty. The system includes the FitCode™ Implant Recognition Engine, optimizing implant selection and positioning for the U2 Total Knee System by United Orthopedic. It operates on a cloud-integrated platform, streamlining data management and collaboration among surgical teams. The system has received FDA 510(k) clearance, ensuring compliance with medical device standards. By reducing reliance on traditional CT scans, it offers a safer and more cost-effective approach to preoperative planning, aiming to improve patient outcomes and surgical efficiency.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "surgical Planning",
    "imaging Software",
    "Clinical",
    "Diagnostic",
    "Surgical Planning",
    "Medical Imaging",
    "Orthopedics"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "orthopedic surgeons",
    "surgical planners",
    "medical device manufacturers",
    "healthcare providers"
  ],
  "specialties": [
    "Orthopedics",
    "Knee Surgery",
    "Sports Medicine",
    "Rehabilitation"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "enterprise_quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2019",
  "deployment_model": [
    "SaaS"
  ],
  "os_platforms": [
    "Web"
  ],
  "features": [
    "Advanced AI Algorithms for X-ray or CT segmentation",
    "3D Anatomical Modeling for personalized surgical planning",
    "FitCode™ Implant Recognition Engine for implant selection and positioning",
    "Cloud-Integrated Platform for efficient data management",
    "510(k) Cleared for patient-specific instrument design",
    "Precision and Customization of surgical guides and plans"
  ],
  "optional_modules": [
    "Virtual Surgical Planning",
    "Personalized Solutions",
    "3D Printing by 3D Systems",
    "Medical Device Surgical Case Plan"
  ],
  "integrations": [
    "United Orthopedic’s U2 Knee System",
    "3D Systems Healthcare"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "HITECH",
    "SOC 2 Type II",
    "FDA 510(k) Clearance"
  ],
  "certifications": [
    "FDA 510(k) Clearance",
    "SOC 2 Type II",
    "HIPAA",
    "HITECH"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "Audit Logs",
    "2FA"
  ],
  "privacy_features": [
    "BAA available",
    "Consent Management",
    "Anonymization",
    "Data Minimization"
  ],
  "data_residency": "US-only",
  "customers": [
    "United Orthopedic Group"
  ],
  "user_reviews": [
    "The AI-driven approach has significantly improved our surgical planning efficiency.",
    "Integrating the Intelligent Surgery Knee system streamlined our preoperative processes.",
    "The 3D anatomical modeling feature provides precise visualization for better surgical outcomes.",
    "FitCode™ has optimized our implant selection, reducing time spent on planning.",
    "The cloud-integrated platform allows seamless collaboration among surgical teams."
  ],
  "ratings": [
    "FDA 510(k) Cleared for Patient-Specific Instrumentation",
    "AI-Powered Surgical Planning Solution",
    "Advanced Imaging and 3D Modeling Capabilities",
    "FitCode™ Implant Recognition Engine",
    "Cloud-Based Data Management Platform"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2024",
  "integration_partners": [
    "3D Systems",
    "United Orthopedic Group"
  ],
  "id": "SW0275",
  "slug": "intelligent-surgery-knee",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/intelligent-surgery-knee.json"
  }
}